The Future Of Clinical Evidence Requirements For Medical Devices in the EU
This article was originally published in SRA
Executive Summary
The Council of the European Union’s agreed amendments to the requirements for clinical evaluation reports under the new Medical Device Regulation are substantial. And so are its proposed amendments to clinical investigations and post-market clinical follow up. Sarah Sorrel explains why these amendments are likely to become reality, how companies may be required to adjust and what demands they will have to meet.
You may also be interested in...
The Future Of Clinical Evidence Requirements For CE Marking
The Council of the EU’s agreed amendments to the requirements for clinical evaluation reports under the new Medical Device Regulation are substantial. And so are its proposed amendments to clinical investigations and post-market clinical follow up. Sarah Sorrel explains why these amendments are likely to become reality, how companies may be required to adjust and what demands they will have to meet
The knock-on effect of EU drug trials legislation on medical devices
The EU Clinical Trials Directive technically applies only to drugs but has had a significant impact on medical device clinical investigations. Now that the directive is being revised, medical devices will be further affected. Sarah Sorrel of MedPass International reports on some of the likely changes